Bioequivalence of Topical Dermatological Dosage Forms – Methods of Evaluation of Bioequivalence

Shah, Vinod P.; Flynn, Gordon L.; Yacobi, Avraham; Maibach, Howard I.; Bon, Charles; Fleischer, Nicholas M.; Franz, Thomas; Kaplan, Stanley A.; Kawamoto, Jeff; Lesko, Lawrence J.; Marty, Jean‐Paul; Pershing, Lynn K.; Schaefer, Hans; Sequeira, Joel; Shrivastava, S. P.; Wilkin, Jonathan K.; Williams, Roger L.

doi:10.1159/000029817

Cited by 72 publications

(74 citation statements)

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“…These parameters and the drug penetration profiles provide information with which to assess bioavailability and demonstrate bioequivalence between different formulations. It has been suggested that since the stratum corneum, SC, is the principal barrier to drug absorption, that kinetic data of drug passage through this layer can be related to bioavailability in the target tissue [1][2][3].…”

Section: Introductionmentioning

confidence: 99%

“…The tape stripping technique has attracted considerable interest from regulatory bodies, such as the US Food and Drug Administration, as a means to determine dermato-pharmacokinetic parameters, and ultimately test bioequivalence between formulations [2,3]. Tape stripping involves the sequential removal of layers of the stratum corneum using adhesive tapes.…”

Section: Introductionmentioning

confidence: 99%

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The determination of stratum corneum thickness An alternative approach

Russell¹,

Wiedersberg²,

Delgado‐Charro³

2008

European Journal of Pharmaceutics and Biopharmaceutics

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The individual thickness of the stratum corneum is required to normalize drug permeation profiles in dermatopharmacokinetic studies. The thickness is often estimated using tape-striping combined with transepidermal water loss measurements. A linear transformation of Fick's first law is used to relate the progressively thinner barrier with the corresponding increase in transepidermal water loss and to estimate the thickness by linear regression. However, the data from an important subset of subjects are poorly fitted to this linear model. This is typically due to the removal of loose outer layers of stratum corneum, which do not contribute significantly to barrier function. This work proposes two alternative non-linear models. All three models were used to fit data from 31 in vivo tape-striping experiments and their outcomes and goodness-of-fit compared. The results suggest that the linear model may overestimate the stratum corneum thickness and is open to subjectivity regarding the selection of data points to be fitted. The non-linear models satisfactorily fitted all the data, including all data points. No significant differences were found between the thicknesses derived from the two non-linear models. However, the analysis of the goodness-of-fit of the models to the data suggests a preference for a baseline-corrected approach.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The determination of stratum corneum thickness An alternative approach

Russell¹,

Wiedersberg²,

Delgado‐Charro³

2008

European Journal of Pharmaceutics and Biopharmaceutics

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“…The tape-stripping procedure (see the previous section) was performed by exerting the pressure just with the forefinger. To increase reproducibility, the procedure was carried out by the same person according to the AAPS/FDA Workshop report (29) and the Guidance for Industry (30).…”

Section: In-vivo Experimentsmentioning

confidence: 99%

A strategy for in-silico prediction of skin absorption in man

Selzer

Neumann

et al. 2015

European Journal of Pharmaceutics and Biopharmaceutics

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“…The implantation procedure involves initial insertion of cannnulae into the skin and subsequent threading of the DMD membranes through the cannulae within the volar aspect of the forearm of human volunteers is illustrated in Figure 9 (Tettey-Amlalo, 2009). Once the microdialysis membranes have been inserted through the cannulae and placed under the skin, the probes are connected to a microdialysis pump (Figure 10) DMD has been considered as a promising technique for the assessment of bioavailability and bioequivalence of topical formulations and has attracted a great deal of interest among research scientists, dermatologists, and the pharmaceutical industry (Groth, 1996;Shah et al, 1998a;Shah et al, 1998b;Benfeldt et al, 2007). The technique is minimally invasive and capable of producing concentration-time profiles sampled directly in the dermis, the target tissue, and is therefore suited to study the local and/or regional delivery of drugs following topical administration.…”

Section: Dermal Microdialysismentioning

confidence: 99%

Strategies for the Bioequivalence Assessment of Topical Dermatological Dosage Forms

Kanfer¹

2010

JBB

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Bioequivalence of Topical Dermatological Dosage Forms – Methods of Evaluation of Bioequivalence

Cited by 72 publications

References 0 publications

The determination of stratum corneum thickness An alternative approach

The determination of stratum corneum thickness An alternative approach

A strategy for in-silico prediction of skin absorption in man

Strategies for the Bioequivalence Assessment of Topical Dermatological Dosage Forms

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